Ketum and Pain Tolerence

Pain Clinical Trial

Official title:

Ketum and Pain Tolerence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414099
• Other study ID #: USM/JEPeM/17050243
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: Universiti Sains Malaysia
• Contact: Mohd Bazlan Hafidz Mukrim, BSc
• Phone: 609-7672354
• Email: bazlan[@]usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Description:

Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months. - Exclusion Criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing. -

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketum
Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture
• Placebo
Placebo drink matched for taste and appereance

Locations

Country	Name	City	State
Malaysia	Centre for Drug Research, Univerisiti Sains Malaysia	George Town	Penang

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	Yale University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain tolerance	The duration (seconds) participants can keep their hands immersed in the water bath	3 hours